Dose Escalation only: Enzalutamide-naïve patients following prior progression on abiraterone by PCWG2 criteria and within 12 weeks of discontinuing abiraterone

Dose Confirmation Cohort A (DC-A) only: Currently receiving enzalutamide as most recent systemic therapy for mCRPC and have experienced PSA progression by PCWG2 criteria in the absence of radiographic and/or clinical progression. Patients may or may not have experienced prior progression on abiraterone.

You CAN'T join if...

Any history of brain metastases or prior seizure or conditions predisposing to seizure activity

Have previously received an investigational BET inhibitor (including previous participation in this study or Study ZEN003694-001)

Have received prior systemic anti-cancer therapy (including abiraterone) or investigational therapy within 2 weeks or five half-lives, whichever is shorter, prior to the first administration of study drug

Radiation therapy within 2 weeks of the first administration of study drug

Have received prior chemotherapy in the metastatic castration-resistant setting (prior chemotherapy in the hormone-sensitive setting is allowed provided last dose was at least 6 months prior to study entry)

Have received prior investigational anti-androgen therapy, including ARN-509

Currently receiving medications known to be strong inhibitors of CYP2C8, strong inducers (except enzalutamide) or inhibitors of CYP3A4 and substrates of CYP3A4,CYP2C9 and CYP2C19 with a narrow therapeutic window. Strong inducers, inhibitors and substrates must be discontinued at least 7 days prior to the first administration of study drug.

Not a candidate for enzalutamide treatment, in the opinion of the Investigator

Locations

University of California San Francisco Medical Centeraccepting new patientsSan FranciscoCaliforniaUnited States

University of California Los Angeles Medical Centeraccepting new patientsLos AngelesCaliforniaUnited States